NCT05373615

Cefiderocol Plasma Concentrations in Patients Receiving Renal Replacement Therapy

Effect of Continuous Renal Replacement Therapy and Residual Renal Clearance on Cefiderocol Pharmacokinetics in Critically Ill Adult Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Hartford Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

Continuous renal replacement therapies (CRRT) such as continuous venovenous hemofiltration are used to provide renal support for critically ill patients with acute kidney injury (AKI), particularly patients who are hemodynamically unstable. It is well known that critically ill patients may experience alterations in antibiotic pharmacokinetics, and as a result, dosing modifications are generally required. There is a need to understand how CRRT affect the pharmacokinetics and disposition of drugs. This study is designed to assess the pharmacokinetics of the new broad-spectrum antibiotic, Cefiderocol, in critically ill patient receiving CRRT.

Detailed description

This is a prospective, multi-center, open-label, Phase 1b, pharmacokinetic study of Cefiderocol in 16 critically ill patients receiving CRRT support. Informed consent will be collected from all study participants, legal authorized representative, or their next of kin in order to participate. This is not a treatment study; all participants will receive standard of care antibiotics which may include cefiderocol as necessary to treat any current infection.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Cefiderocol	After receipt of Cefiderocol, blood samples will be collected at various time points to determine the pharmacokinetics of Cefiderocol

Timeline

• Start date: 2022-07-25
• Primary completion: 2024-11-20
• Completion: 2024-11-20
• First posted: 2022-05-13
• Last updated: 2024-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study